Trial Outcomes & Findings for A Study of CK-1827452 Infusion in Stable Heart Failure (NCT NCT00624442)
NCT ID: NCT00624442
Last Updated: 2021-05-14
Results Overview
Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
4 days
Results posted on
2021-05-14
Participant Flow
The recruitment period was from April 2007 to January 2009.
Participant milestones
| Measure |
Cohort 1
4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
|
Cohort 2
4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
|
Cohort 3
4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
|
Cohort 4
4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
|
Cohort 5
2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
10
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of CK-1827452 Infusion in Stable Heart Failure
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
|
Cohort 2
n=9 Participants
4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
|
Cohort 3
n=10 Participants
4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
|
Cohort 4
n=8 Participants
4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
|
Cohort 5
n=10 Participants
2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 18.0 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 14.0 • n=21 Participants
|
57.5 years
STANDARD_DEVIATION 13.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Georgia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Russian Federation
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
11 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
29 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.
Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Outcome measures
| Measure |
>0-100 ng/mL
n=32 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>100-200 ng/mL
n=30 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>200-300 ng/mL
n=27 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>300-400 ng/mL
n=22 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>400-500 ng/mL
n=17 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>500 ng/mL
n=25 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
Cohort 3: 0.5 mg/kg/h + 0.05 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.50 mg/kg/h IV for 1 hour (loading) + 0.05 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 3: 1.0 mg/kg/h + 0.1 mg/kg/h
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour (loading) + 0.1 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 4: 0.25 mg.kg.h + 0.125 mg/kg/h + 0.025 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour + 0.125 mg/kg/h IV for 1 hour + 0.025 mg/kg/h IV for 22 hours
|
Cohort 4: 0.5 mg/kg/h + 0.25 mg/kg/h + 0.05 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.5 mg/kg/h IV for 1 hour + 0.25 mg/kg/h IV for 1 hour + 0.05 mg/kg/h IV for 22 hours
|
Cohort 4: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 22 hours
|
Cohort 5: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 70 hours
|
Cohort 5: 0.75 mg/kg/h + 0.375 mg/kg/h + 0.075 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.75 mg/kg/h IV for 1 hour + 0.375 mg/kg/h IV for 1 hour + 0.075 mg/kg/h IV for 70 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations
Ejection Fraction msec Change from Baseline
|
1 msec
Standard Error 4
|
18 msec
Standard Error 4
|
47 msec
Standard Error 5
|
58 msec
Standard Error 6
|
59 msec
Standard Error 6
|
80 msec
Standard Error 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations
# of Echocardiographic Observations (no units)
|
84 msec
Standard Error 0
|
62 msec
Standard Error 0
|
42 msec
Standard Error 0
|
24 msec
Standard Error 0
|
20 msec
Standard Error 0
|
46 msec
Standard Error 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.
Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Outcome measures
| Measure |
>0-100 ng/mL
n=31 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>100-200 ng/mL
n=28 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>200-300 ng/mL
n=25 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>300-400 ng/mL
n=21 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>400-500 ng/mL
n=14 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>500 ng/mL
n=23 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
Cohort 3: 0.5 mg/kg/h + 0.05 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.50 mg/kg/h IV for 1 hour (loading) + 0.05 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 3: 1.0 mg/kg/h + 0.1 mg/kg/h
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour (loading) + 0.1 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 4: 0.25 mg.kg.h + 0.125 mg/kg/h + 0.025 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour + 0.125 mg/kg/h IV for 1 hour + 0.025 mg/kg/h IV for 22 hours
|
Cohort 4: 0.5 mg/kg/h + 0.25 mg/kg/h + 0.05 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.5 mg/kg/h IV for 1 hour + 0.25 mg/kg/h IV for 1 hour + 0.05 mg/kg/h IV for 22 hours
|
Cohort 4: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 22 hours
|
Cohort 5: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 70 hours
|
Cohort 5: 0.75 mg/kg/h + 0.375 mg/kg/h + 0.075 mg/kg/h
Subjects received the following CK-1827452 regimen: 0.75 mg/kg/h IV for 1 hour + 0.375 mg/kg/h IV for 1 hour + 0.075 mg/kg/h IV for 70 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations
# of Echocardiographic Observations (no units)
|
81 Percentage of change
Standard Error 0
|
56 Percentage of change
Standard Error 0
|
37 Percentage of change
Standard Error 0
|
23 Percentage of change
Standard Error 0
|
17 Percentage of change
Standard Error 0
|
44 Percentage of change
Standard Error 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations
Fractional Shortening Percent Change from Baseline
|
1 Percentage of change
Standard Error 1
|
1 Percentage of change
Standard Error 1
|
3 Percentage of change
Standard Error 1
|
3 Percentage of change
Standard Error 1
|
2 Percentage of change
Standard Error 1
|
5 Percentage of change
Standard Error 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 daysDetermined by evaluation of plasma concentrations from blood samples collected prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 and 48 hours after initiation of study drug infusion
Outcome measures
| Measure |
>0-100 ng/mL
n=8 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>100-200 ng/mL
n=9 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>200-300 ng/mL
n=16 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>300-400 ng/mL
n=9 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>400-500 ng/mL
n=6 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>500 ng/mL
n=10 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
Cohort 3: 0.5 mg/kg/h + 0.05 mg/kg/h
n=9 Participants
Subjects received the following CK-1827452 regimen: 0.50 mg/kg/h IV for 1 hour (loading) + 0.05 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 3: 1.0 mg/kg/h + 0.1 mg/kg/h
n=8 Participants
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour (loading) + 0.1 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 4: 0.25 mg.kg.h + 0.125 mg/kg/h + 0.025 mg/kg/h
n=8 Participants
Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour + 0.125 mg/kg/h IV for 1 hour + 0.025 mg/kg/h IV for 22 hours
|
Cohort 4: 0.5 mg/kg/h + 0.25 mg/kg/h + 0.05 mg/kg/h
n=9 Participants
Subjects received the following CK-1827452 regimen: 0.5 mg/kg/h IV for 1 hour + 0.25 mg/kg/h IV for 1 hour + 0.05 mg/kg/h IV for 22 hours
|
Cohort 4: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
n=7 Participants
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 22 hours
|
Cohort 5: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
n=8 Participants
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 70 hours
|
Cohort 5: 0.75 mg/kg/h + 0.375 mg/kg/h + 0.075 mg/kg/h
n=2 Participants
Subjects received the following CK-1827452 regimen: 0.75 mg/kg/h IV for 1 hour + 0.375 mg/kg/h IV for 1 hour + 0.075 mg/kg/h IV for 70 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CK-1827452 Maximum Observed Plasma Concentration (Cmax)
|
96.1 nanogram/milliliter
Standard Deviation 27.8
|
195.0 nanogram/milliliter
Standard Deviation 69.4
|
347.1 nanogram/milliliter
Standard Deviation 108.6
|
558.1 nanogram/milliliter
Standard Deviation 156.5
|
635.9 nanogram/milliliter
Standard Deviation 158.0
|
165.3 nanogram/milliliter
Standard Deviation 51.4
|
279.9 nanogram/milliliter
Standard Deviation 55.0
|
633.0 nanogram/milliliter
Standard Deviation 161.5
|
177.9 nanogram/milliliter
Standard Deviation 103.4
|
403.3 nanogram/milliliter
Standard Deviation 226.2
|
681.4 nanogram/milliliter
Standard Deviation 159.2
|
884.5 nanogram/milliliter
Standard Deviation 316.2
|
726.9 nanogram/milliliter
Standard Deviation 62.4
|
SECONDARY outcome
Timeframe: 2 daysDetermined by evaluation of plasma concentrations from blood samples collected prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 and 48 hours after initiation of study drug infusion
Outcome measures
| Measure |
>0-100 ng/mL
n=8 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>100-200 ng/mL
n=9 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>200-300 ng/mL
n=16 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>300-400 ng/mL
n=9 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>400-500 ng/mL
n=6 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
>500 ng/mL
n=10 Participants
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
|
Cohort 3: 0.5 mg/kg/h + 0.05 mg/kg/h
n=9 Participants
Subjects received the following CK-1827452 regimen: 0.50 mg/kg/h IV for 1 hour (loading) + 0.05 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 3: 1.0 mg/kg/h + 0.1 mg/kg/h
n=8 Participants
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour (loading) + 0.1 mg/kg/h IV for 23 hours (maintenance)
|
Cohort 4: 0.25 mg.kg.h + 0.125 mg/kg/h + 0.025 mg/kg/h
n=8 Participants
Subjects received the following CK-1827452 regimen: 0.25 mg/kg/h IV for 1 hour + 0.125 mg/kg/h IV for 1 hour + 0.025 mg/kg/h IV for 22 hours
|
Cohort 4: 0.5 mg/kg/h + 0.25 mg/kg/h + 0.05 mg/kg/h
n=9 Participants
Subjects received the following CK-1827452 regimen: 0.5 mg/kg/h IV for 1 hour + 0.25 mg/kg/h IV for 1 hour + 0.05 mg/kg/h IV for 22 hours
|
Cohort 4: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
n=7 Participants
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 22 hours
|
Cohort 5: 1.0 mg/kg/h + 0.5 mg/kg/h + 0.1 mg/kg/h
n=8 Participants
Subjects received the following CK-1827452 regimen: 1.0 mg/kg/h IV for 1 hour + 0.5 mg/kg/h IV for 1 hour + 0.1 mg/kg/h IV for 70 hours
|
Cohort 5: 0.75 mg/kg/h + 0.375 mg/kg/h + 0.075 mg/kg/h
n=2 Participants
Subjects received the following CK-1827452 regimen: 0.75 mg/kg/h IV for 1 hour + 0.375 mg/kg/h IV for 1 hour + 0.075 mg/kg/h IV for 70 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CK-1827452 Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUClast)
|
1102.2 hour x nanogram/milliliter
Standard Deviation 257.6
|
2314.3 hour x nanogram/milliliter
Standard Deviation 640.9
|
4252.7 hour x nanogram/milliliter
Standard Deviation 1296.7
|
6060.7 hour x nanogram/milliliter
Standard Deviation 1741.7
|
8495.7 hour x nanogram/milliliter
Standard Deviation 3178.3
|
3982.7 hour x nanogram/milliliter
Standard Deviation 1070.2
|
8120.5 hour x nanogram/milliliter
Standard Deviation 2268.9
|
18450.7 hour x nanogram/milliliter
Standard Deviation 4747.8
|
4399.0 hour x nanogram/milliliter
Standard Deviation 1483.2
|
10624.8 hour x nanogram/milliliter
Standard Deviation 5168.3
|
19394.3 hour x nanogram/milliliter
Standard Deviation 4230.6
|
59044.6 hour x nanogram/milliliter
Standard Deviation 17693.2
|
43605.5 hour x nanogram/milliliter
Standard Deviation 3551.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2, Loading Dose of 2.2 mg/kg/hr
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5, Loading Dose of 0.75 mg/kg/hr
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5, Loading Dose of 1.0 mg/kg/hr
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
|
Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr
n=8 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr
n=9 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr
n=16 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr
n=6 participants at risk
Loading dose is first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr
n=8 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohort 2, Loading Dose of 2.2 mg/kg/hr
n=1 participants at risk
Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
|
Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr
n=18 participants at risk
Loading dose is first hour of IV infusion.
|
Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr
n=18 participants at risk
Loading dose is first hour of IV infusion.
|
Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr
n=16 participants at risk
Loading dose is first hour of IV infusion.
|
Cohort 5, Loading Dose of 0.75 mg/kg/hr
n=2 participants at risk
Loading dose is first hour of IV infusion.
|
Cohort 5, Loading Dose of 1.0 mg/kg/hr
n=8 participants at risk
Loading dose is first hour of IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Non ST elevation MI in patient with drug overdose
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
100.0%
1/1 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Metabolism and nutrition disorders
Septicemia in setting of diabetic foot ulcer
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
|
Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr
n=8 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr
n=9 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr
n=16 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr
n=6 participants at risk
Loading dose is first hour of IV infusion.
|
Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr
n=8 participants at risk
Loading dose is the first hour of IV infusion.
|
Cohort 2, Loading Dose of 2.2 mg/kg/hr
n=1 participants at risk
Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
|
Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr
n=18 participants at risk
Loading dose is first hour of IV infusion.
|
Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr
n=18 participants at risk
Loading dose is first hour of IV infusion.
|
Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr
n=16 participants at risk
Loading dose is first hour of IV infusion.
|
Cohort 5, Loading Dose of 0.75 mg/kg/hr
n=2 participants at risk
Loading dose is first hour of IV infusion.
|
Cohort 5, Loading Dose of 1.0 mg/kg/hr
n=8 participants at risk
Loading dose is first hour of IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Orthostatic hypotension
|
4.9%
2/41 • Number of events 2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
16.7%
1/6 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
50.0%
1/2 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • Number of events 2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/41 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
6.2%
1/16 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Investigations
Troponin increased
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
100.0%
1/1 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
25.0%
2/8 • Number of events 2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
16.7%
1/6 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
16.7%
1/6 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
General disorders
Infusion site pain
|
2.4%
1/41 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
5.6%
1/18 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/41 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/41 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
16.7%
1/6 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/9 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
6.2%
1/16 • Number of events 1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/6 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/1 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/18 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/16 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/2 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
0.00%
0/8 • 5 weeks
Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
|
Additional Information
Medical Director
Cytokinetics, Inc.
Phone: (650) 624-3011
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor intends to publish the results of the trial in collaboration with the Investigators.
- Publication restrictions are in place
Restriction type: OTHER